MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-09 for VICTORY WHITE VELCRO 10 WIDE 3440-W-10.0 manufactured by Dr. Comfort, A Djo, Llc Company.
[132567432]
It was reported that the patient developed bleeding blisters during the break-in period of wearing the shoes. There was no report medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
[134772408]
The shoes were evaluated and no defect was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008579854-2019-00002 |
| MDR Report Key | 8231780 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-09 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2018-12-19 |
| Date Added to Maude | 2019-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BECKER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DR. COMFORT, A DJO, LLC COMPANY |
| Manufacturer Street | 10300 ENTERPRISE DR. |
| Manufacturer City | MEQUON WI 53092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VICTORY WHITE VELCRO 10 WIDE |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2019-01-09 |
| Returned To Mfg | 2018-12-19 |
| Model Number | 3440-W-10.0 |
| Lot Number | FY--39--18 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR. COMFORT, A DJO, LLC COMPANY |
| Manufacturer Address | 10300 ENTERPRISE DR. MEQUON WI 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-09 |